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CAR T-cell Therapy

Cytotoxic T Lymphocytes for Virus-Related Cancer

Phase 2

Recruiting

Led By Amanda Olson

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Negative pregnancy test in female patients of childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization; women of child bearing potential must be willing to use an effective contraceptive measure while on study

Patients with microscopic hematuria OR biopsy proven BK nephritis and urine or blood polymerase chain reaction (PCR) positive for BK virus and/or JC viral encephalitis

Must not have

Patients with active acute graft-versus-host disease (GVHD) grades II-IV

Patients receiving prednisone > 0.5 mg/kg/day at time of enrollment, or have received anti-thymocyte globulin (ATG) within 14 days or have received donor lymphocyte infusion (DLI) or Campath within 28 days of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well cytotoxic T lymphocytes from donors can treat patients with cancer caused by BK or JC viruses.

Who is the study for?

This trial is for patients with various malignancies, HIV/AIDS, history of organ transplant, or Merkel cell carcinoma linked to BK/JC viruses. Participants must have measurable disease and be willing to use contraception if applicable. Excluded are those on high-dose steroids, recent recipients of certain immune therapies, or with active severe infections.

What is being tested?

The study tests donor-derived cytotoxic T lymphocytes (CTLs) against BK and JC viruses in patients with related malignancies. CTLs are blood cells grown in a lab designed to fight these specific viral infections that can complicate transplants.

What are the potential side effects?

While the description doesn't specify side effects, similar treatments may cause immune reactions, fatigue, fever, chills or risk of infection due to the introduction of foreign immune cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant and willing to use birth control during the study.

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I have blood in my urine or kidney inflammation due to BK virus, confirmed by a PCR test.

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I am on antiviral treatments like cidofovir or leflunomide but they are not working.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently experiencing moderate to severe symptoms of graft-versus-host disease.

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I am not currently on high doses of prednisone, nor have I recently received ATG, DLI, or Campath treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Graft-vs-Host Disease

Incidence of adverse events

Response, defined as response (R) = (best response [R1] or second best response [R2])

Secondary study objectives

Glomerular filtration rate

Overall survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (BK-specific cytotoxic T lymphocytes)Experimental Treatment2 Interventions

Patients receive allogeneic BK-specific cytotoxic T-lymphocytes IV over 30 minutes. Patients achieving partial response, stable disease, or progressive disease are eligible for 19 additional infusions of CTL occurring at least 2 weeks after the previous CTL infusion if they meet the eligibility criteria for subsequent therapy.

0 / 5Eligibility criteria met